Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals Industry
Over the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service.
In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry.
Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment.
Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level.
For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies.
Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”.
The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide.
To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”.
Reference
“Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined
I.Introduction Having sustained the negative repercussions following the global financial crisis of 2008, Taiwan’s average economic growth rate decreased from 4.4 percent (during 2000-2007 years) to 3 percent (2008-2012). This phenomenon highlighted the intrinsic problems the Taiwanese economic growth paradigm was facing, seen from the perspective of its development momentum and industrial framework: sluggish growth of the manufacturing industries and the weakening productivity of the service sector. Moreover, the bleak investment climate of the post-2008 era discouraged domestic investors injecting capital into the local economy, rendering a prolonged negative investment growth rate. To further exacerbation, the European Debt Crisis of 2011 – 2012 has impacted to such detriment of private investors and enterprises, that confidence and willingness to invest in the private sector were utterly disfavored. It can be observed that as Taiwan’s industrial core strength is largely concentrated within the the manufacturing sector, the service sector, on the other hand, dwindles. Similarly, the country’s manufacturing efforts have been largely centered upon the Information & Communications Technology (ICT) industry, where the norm of production has been the fulfillment of international orders in components manufacturing and Original Equipment Manufacturing (OEM). Additionally, the raising-up of society’s ecological awareness has further halted the development of the upstream petrochemical and metal industry. Consumer goods manufacturing growth impetus too has been stagnated. Against the backdrop of the aforementioned factors at play as well as the competitive pressure exerted on Taiwan by force of the rapid global and regional economic integration developments, plans to upgrade and transform the existing industrial framework, consequently, arises out as an necessary course of action by the state. Accordingly, Taiwan’s Executive Yuan approved and launched the “Industrial Upgrading and Transformation Action Plan”, on the 13th of October 2014, aiming to reform traditional industries, reinforcing core manufacturing capacities and fostering innovative enterprises, through the implementation of four principal strategies: Upgrading of Product Grade and Value, Establishment of Complete Supply Chain, Setting-up of System Integration Solutions Capability, Acceleration of Growth in the Innovative Sector. II.Current challenges confronting Taiwanese industries 1.Effective apportionment of industrial development funds Despite that Research and Development (R&D) funds takes up 3.02% of Taiwan’s national GDP, there has been a decrease of the country’s investment in industrial and technology research. Currently Taiwan’s research efforts have been directed mostly into manufacturing process improvement, as well as into the high-tech sector, however, traditional and service industries on the other hand are lacking in investments. If research funds for the last decade could be more efficiently distributed, enterprises would be equally encouraged to likewise invest in innovation research. However, it should be noted that Taiwan’s Small and Medium Enterprises (SME) based on their traditional developmental models, do not place research as their top priority. Unlike practices in countries such as Germany and Korea, the research fund input by private enterprises into academic and research institutions is still a relatively unfamiliar exercise in Taiwan. With regards to investment focus, the over-concentration in ICTs should be redirected to accommodate growth possibilities for other industries as well. It has been observed that research investments in the pharmaceutical and electric equipment manufacturing sector has increased, yet in order to not fall into the race-to-the-bottom trap for lowest of costs, enterprises should be continually encouraged to develop high-quality and innovative products and services that would stand out. 2.Human talent and labor force issues Taiwan’s labor force, age 15 to 64, will have reached its peak in 2015, after which will slowly decline. It has been estimated that in 2011 the working population would amount to a meager 55.8%. If by mathematical deduction, based on an annual growth rate of 3%, 4% and 5%, in the year 2020 the labor scarcity would increase from 379,000, 580,000 to 780,000 accordingly. Therefore, it is crucial that productivity must increase, otherwise labor shortage of the future will inevitably stagnate economic growth. Notwithstanding that Taiwan’s demographical changes have lead to a decrease in labor force; the unfavorable working conditions so far has induced skilled professionals to seek employment abroad. The aging society along with decrease in birth rates has further exacerbated the existing cul-de-sac in securing a robust workforce. In 1995 the employment rate under the age of 34 was 46.35%, yet in 2010 it dropped to a daunting 37.6%. 3.Proportional land-use and environmental concerns Taiwan’s Environmental Impact Assessment (EIA) is a time-consuming and often unpredictable process that has substantially deterred investor’s confidence. Additionally, there exists a disproportionate use of land resources in Taiwan, given that demand for its use predominantly stems from the northern and middle region of the country. Should the government choose to balance out the utilization of land resources across Taiwan through labor and tax policies, the situation may be corrected accordingly. III.Industrial Upgrading and Transformation Strategies The current action plan commences its implementation from October 2014 to end of December 2024. The expected industrial development outcomes are as follows: (1) Total output value of the manufacturing sector starting from 2013 at NTD 13.93 trillion is expected to grow in 2020 to NTD 19.46 trillion. (2) Total GDP of the service sector, starting at 3.03 trillion from 2011 is expected to grow in 2020 to 4.75 trillion NTD. 1.Strategy No.1 : Upgrading of product grade and value Given that Taiwan’s manufacturing industry’s rate for added value has been declining year after year, the industry should strive to evolve itself to be more qualitative and value-added oriented, starting from the development of high-end products, including accordingly high-value research efforts in harnessing essential technologies, in the metallic materials, screws and nuts manufacturing sector, aviation, petrochemical, textile and food industries etc. (1) Furtherance of quality research Through the employment of Technology Development Program (TDP) Organizations, Industrial TDP and Academic TDP, theme-based and pro-active Research and Development programs, along with other related secondary assistance measures, the industrial research capability will be expanded. The key is in targeting research in high-end products so that critical technology can be reaped as a result. (2) Facilitating the formation of research alliances with upper-, mid- and downstream enterprises Through the formation of research and development alliances, the localization of material and equipment supply is secured; hence resulting in national autonomy in production capacity. Furthermore, supply chain between industrial component makers and end-product manufacturers are to be conjoined and maintained. National enterprises too are to be pushed forth towards industrial research development, materializing the technical evolution of mid- and downstream industries. (3) Integrative development assistance in Testing and Certification The government will support integrative development in testing and certification, in an effort to boost national competitive advantage thorough benefitting from industrial clusters as well as strengthening value-added logistics services, including collaboration in related value-added services. (4) Establishment of international logistics centre Projection of high-value product and industrial cluster image, through the establishment of an international logistics centre. 2.Strategy No.2 : Establishment of a Complete Supply Chain The establishing a robust and comprehensive supply chain is has at its aim transforming national production capabilities to be sovereign and self-sustaining, without having to resort to intervention of foreign corporations. This is attained through the securing of key materials, components and equipments manufacturing capabilities. This strategy finds its application in the field of machine tool controllers, flat panel display materials, semiconductor devices (3D1C), high-end applications processor AP, solar cell materials, special alloys for the aviation industry, panel equipment, electric vehicle motors, power batteries, bicycle electronic speed controller (ESC), electrical silicon steel, robotics, etc. The main measures listed are as follows: (1) Review of industry gaps After comprehensive review of existing technology gaps depicted by industry, research and academic institutions, government, strategies are to be devised, so that foreign technology can be introduced, such as by way of cooperative ventures, in order to promote domestic autonomous development models. (2) Coordination of Research and Development unions – building-up of autonomous supply chain. Integrating mid- and downstream research and development unions in order to set up a uniform standard in equipment, components and materials in its functional specifications. (3) Application-theme-based research programs Through the release of public notice, industries are invited to submit research proposals focusing on specific areas, so that businesses are aided in developing their own research capabilities in core technologies and products. (4) Promotion of cross-industry cooperation to expand fields of mutual application Continuously expanding field of technical application and facilitating cross-industry cooperation; Taking advantage of international platform to induce cross-border technical collaboration. 3.Strategy No.3 : Setting-up of System Integration Solutions capability Expanding turnkey-factory and turnkey-project system integration capabilities, in order to increase and stimulate export growth; Combination of smart automation systems to strengthen hardware and software integration, hence, boosting system integration solution capacity, allowing stand-alone machinery to evolve into a total solution plant, thus creating additional fields of application and services, effectively expanding the value-chain. These type of transitions are to be seen in the following areas: turnkey-factory and turnkey-project exports, intelligent automated manufacturing, cloud industry, lifestyle (key example: U-Bike in Taipei City) industry, solar factory, wood-working machinery, machine tools, food/paper mills, rubber and plastic machines sector. Specific implementation measure s includes: (1) Listing of national export capability – using domestic market as test bed for future global business opportunities Overall listing of all national system integration capabilities and gaps and further assistance in building domestic “test beds” for system integration projects, so that in the future system-integration solutions can be exported abroad, especially to the emerging economies (including ASEAN, Mainland China) where business opportunities should be fully explored. The current action plan should simultaneously assist these national enterprises in their marketing efforts. (2) Formation of System Integration business alliances and Strengthening of export capability through creation of flagship team Formation of system integration business alliances, through the use of national equipment and technology, with an aim to comply with global market’s needs. Promotion of export of turnkey-factory and turnkey-projects, in order to make an entrance to the global high-value system integration market. Bolstering of international exchanges, allowing European and Asian banking experts assist Taiwanese enterprises in enhancing bids efforts. (3) Establishing of financial assistance schemes to help national enterprises in their overseas bidding efforts Cooperation with financial institutes creating financial support schemes in syndicated loans for overseas bidding, in order to assist national businesses in exporting their turnkey-factories and turnkey-solutions abroad. 4. Strategy No.4 : Acceleration of growth in the innovative sectors Given Taiwan economy’s over-dependence on the growth of the electronics industry, a new mainstream industry replacement should be developed. Moreover, the blur distinction between the manufacturing, service and other industries, presses Taiwan to develop cross-fields of application markets, so that the market opportunities of the future can be fully explored. Examples of these markets include: Smart Campus, Intelligent Transportation System, Smart Health, Smart City, B4G/5G Communications, Strategic Service Industries, Next-Generation Semiconductors, Next-Generation Visual Display, 3D Printing, New Drugs and Medical Instruments, Smart Entertainment, Lifestyle industry (for instance the combination of plan factory and leisure tourism), offshore wind power plant, digital content (including digital learning), deep sea water. Concrete measures include: (1) Promotion of cooperation between enterprises and research institutions to increase efficiency in the functioning of the national innovation process Fostering of Industry-academic cooperation, combining pioneering academic research results with efficient production capability; Cultivation of key technology, accumulation of core intellectual property, strengthening integration of industrial technology and its market application, as well as, establishment of circulation integration platform and operational model for intellectual property. (2) Creating the ideal Ecosystem for innovation industries Strategic planning of demo site, constructing an ideal habitat for the flourishing of innovation industries, as well as the inland solution capability. Promotion of international-level testing environment, helping domestic industries to be integrated with overseas markets and urging the development of new business models through open competition. Encouraging international cooperation efforts, connecting domestic technological innovation capacities with industries abroad. (3) Integration of Cross-Branch Advisory Resources and Deregulation to further support Industrial Development Cross-administrations consultations further deregulation to support an ideal industrial development environment and overcoming traditional cross-branch developmental limitations in an effort to develop innovation industries. IV. Conclusion Taiwan is currently at a pivotal stage in upgrading its industry, the role of the government will be clearly evidenced by its efforts in promoting cross-branch/cross-fields cooperation, establishing a industrial-academic cooperation platform. Simultaneously, the implementation of land, human resources, fiscal, financial and environmental policies will be adopted to further improve the investment ambient, so that Taiwan’s businesses, research institutions and the government could all come together, endeavoring to help Taiwan breakthrough its currently economic impasse through a thorough industrial upgrading. Moreover, it can be argued that the real essence of the present action plan lies in the urge to transform Taiwan’s traditional industries into incubation centers for innovative products and services. With the rapid evolution of ICTs, accelerating development and popular use of Big Data and the Internet of Things, traditional industries can no longer afford to overlook its relation with these technologies and the emerging industries that are backed by them. It is only through the close and intimate interconnection between these two industries that Taiwan’s economy would eventually get the opportunity to discard its outdated growth model based on “quantity” and “cost”. It is believed that the aforementioned interaction is an imperative that would allow Taiwanese industries to redefine its own value amidst fierce global market competition. The principal efforts by the Taiwanese government are in nurturing such a dialogue to occur with the necessary platform, as well as financial and human resources. An illustration of the aforementioned vision can be seen from the “Industrie 4.0” project lead by Germany – the development of intelligent manufacturing, through close government, business and academic cooperation, combining the internet of things development, creating promising business opportunities of the Smart Manufacturing and Services market. This is the direction that Taiwan should be leading itself too. References 1.Executive Yuan, Republic of China http://www.ey.gov.tw/en/（last visited: 2015.02.06） 2.Industrial Development Bureau, Ministry of Economic Affairs http://www.moeaidb.gov.tw/（last visited: 2015.02.06） 3.Industrial Upgrading and Transformation Action Plan http://www.moeaidb.gov.tw/external/ctlr?PRO=filepath.DownloadFile&f=policy&t=f&id=4024（last visited: 2015.02.06）
Innovative Practice of Israel's Government ProcurementInnovative Practice of Israel's Government Procurement Government procurement is an important pillar of government services. Because of the huge number of government purchases, government procurement management play an important role in promoting public sector efficiency and building citizenship. Well-designed government procurement systems also help to achieve policy such as environmental protection, innovation, start-ups and the development of small and medium-sized enterprises. Nowadays, countries in the world, especially OECD countries, have been widely practiced with innovative procurement to stimulate innovation and start-ups, and call Innovation procurement can deliver solutions to challenges of public interest and ICTs can play a major role in this. However, in the OECD countries, in addition to the advanced countries that have been developed, many developing countries have also used government procurement to stimulate national R & D and innovation with remarkable results. Israel is one of the world's leading technology innovation centers, one of the most innovative economies in the world, continues to leverage its own strengths, support of technology entrepreneurship and unique environment, an international reputation in the high-tech industry, the spirit of technological innovation and novelty. Government procurement is a core element of the activities of Israeli government, agreement with suppliers and compliance with the Mandatory Tenders Law. The main challenge is how to ensure efficiency and maintain government performance while ensuring an equitable and transparent procurement process. Israel’s Mandatory Tenders Law has shown the central role played by the Israeli Supreme Court in creating and developing this law, even in the absence of any procurement legislation, based instead on general principles of administrative law. Once the project of creating a detailed body of public tendering law had been completed, and the legislator was about to step in, the Supreme Court was prepared to step out and transferring the jurisdiction to lower courts. The Knesset passed the Mandatory Tenders Law, and based on it the Government issued the various tendering regulations. Besides, Israel's various international agreements on government procurement, mainly GPA and other bilateral international agreements such as free trade agreements with Mexico and Colombia and free trade agreements and memoranda of understanding with the United States. The practical significance of these commitments can only be understood on the backdrop of Israel’s domestic preference and offset policies. These policies were therefore discussed and analyzed as they apply when none of the international agreements applies. The Challenge Tenders "How to solve the problem of overcrowding in the emergency department and the internal medicine department?" is the first of a series of "problem solicitations" released by the Israeli Ministry of Health which seeks to find a digital solution to the public health system problem, questions from the government while avoiding preconceived prejudices affect the nature of the solution, allowing multiple innovative ideas from different fields to enter the health system, make fair and transparent judgments about the ideal solution to the problem. In order to ensure transparency and integrity, equality, efficiency and competition in the decision-making process, the tender proposed by the Israeli Ministry of Health defines a two-stage tender process. The Ministry of Health of Israel, in order to improve the quality of medical care, shorten the waiting time for hospitalized patients, protect the dignity of patients and their families with patients as its center, and ensure their rights, while alleviating the burden of hospital staff, so as to pass the targeted treatment areas reduce the gap between various residential areas. The Israeli government deals with these issues through challenging tenders and offers a digital solution combined with innovative ideas. The initiative proposed through the development of public service projects can raise the level of public services in the country and help the government to reduce costs and achieve the purpose of promoting innovation with limited conceptual, technical and financial capabilities. In addition, due to the online operation of the challenging tender process throughout the entire process, fair and transparent procedures can be ensured, while public-private partnerships are encouraged to facilitate the implementation of the implementation plan.
The Research on ownership of cell therapy productsThe Research on ownership of cell therapy products 1. Issues concerning ownership of cell therapy products Regarding the issue of ownership interests, American Medical Association(AMA)has pointed out in 2016 that using human tissues to develop commercially available products raises question about who holds property rights in human biological materials[1]. In United States, there have been several disputes concern the issue of the whether the donor of the cell therapy can claim ownership of the product, including Moore v. Regents of University of California(1990)[2], Greenberg v. Miami Children's Hospital Research Institute(2003)[3], and Washington University v. Catalona(2007)[4]. The courts tend to hold that since cells and tissues were donated voluntarily, the donors had already lost their property rights of their cells and tissues at the time of the donation. In Moore case, even if the researchers used Moore’s cells to obtain commercial benefits in an involuntary situation, the court still held that the property rights of removed cells were not suitable to be claimed by their donor, so as to avoid the burden for researcher to clarify whether the use of cells violates the wishes of the donors and therefore decrease the legal risk for R&D activities. United Kingdom Medical Research Council(MRC)also noted in 2019 that the donated human material is usually described as ‘gifts’, and donors of samples are not usually regarded as having ownership or property rights in these[5]. Accordingly, both USA and UK tends to believe that it is not suitable for cell donors to claim ownership. 2. The ownership of cell therapy products in the lens of Taiwan’s Civil Code In Taiwan, Article 766 of Civil Code stipulated: “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Accordingly, many scholars believe that the ownership of separated body parts of the human body belong to the person whom the parts were separated from. Therefore, it should be considered that the ownership of the cells obtained from the donor still belongs to the donor. In addition, since it is stipulated in Article 406 of Civil Code that “A gift is a contract whereby the parties agree that one of the parties delivers his property gratuitously to another party and the latter agrees to accept it.”, if the act of donation can be considered as a gift relationship, then the ownership of the cells has been delivered from donor to other party who accept it accordingly. However, in the different versions of Regenerative Medicine Biologics Regulation (draft) proposed by Taiwan legislators, some of which replace the term “donor” with “provider”. Therefore, for cell providers, instead of cell donors, after providing cells, whether they can claim ownership of cell therapy product still needs further discussion. According to Article 69 of the Civil Code, it is stipulated that “Natural profits are products of the earth, animals, and other products which are produced from another thing without diminution of its substance.” In addition, Article 766 of the Civil Code stipulated that “Unless otherwise provided by the Act, the component parts of a thing and the natural profits thereof, belong, even after their separation from the thing, to the owner of the thing.” Thus, many scholars believe that when the product is organic, original substance and the natural profits thereof are all belong to the owner of the original substance. For example, when proteins are produced from isolated cells, the proteins can be deemed as natural profits and the ownership of proteins and isolated cells all belong to the owner of the cells[6]. Nevertheless, according to Article 814 of the Civil Code, it is stipulated that “When a person has contributed work to a personal property belonging to another, the ownership of the personal property upon which the work is done belongs to the owner of the material thereof. However, if the value of the contributing work obviously exceeds the value of the material, the ownership of the personal property upon which the work is done belongs to the contributing person.” Thus, scholar believes that since regenerative medical technology, which induces cell differentiation, involves quite complex biotechnology technology, and should be deemed as contributing work. Therefore, the ownership of cell products after contributing work should belongs to the contributing person[7]. Thus, if the provider provides the cells to the researcher, after complex biotechnology contributing work, the original ownership of the cells should be deemed to have been eliminated, and there is no basis for providers to claim ownership. However, since the development of cell therapy products involves a series of R&D activities, it still need to be clarified that who is entitled to the ownership of the final cell therapy products. According to Taiwan’s Civil Code, the ownership of product after contributing work should belongs to the contributing person. However, when there are numerous contributing persons, which person should the ownership belong to, might be determined on a case-by-case basis. 3. Conclusion The biggest difference between cell therapy products and all other small molecule drugs or biologics is that original cell materials are provided by donors or providers, and the whole development process involves numerous contributing persons. Hence, ownership disputes are prone to arise. In addition to the above-discussed disputes, United Kingdom Co-ordinating Committee on Cancer Research(UKCCCR)also noted that there is a long list of people and organizations who might lay claim to the ownership of specimens and their derivatives, including the donor and relatives, the surgeon and pathologist, the hospital authority where the sample was taken, the scientists engaged in the research, the institution where the research work was carried out, the funding organization supporting the research and any collaborating commercial company. Thus, the ultimate control of subsequent ownership and patent rights will need to be negotiated[8]. Since the same issues might also occur in Taiwan, while developing cell therapy products, carefully clarifying the ownership between stakeholders is necessary for avoiding possible dispute. [1]American Medical Association [AMA], Commercial Use of Human Biological Materials, Code of Medical Ethics Opinion 7.3.9, Nov. 14, 2016, https://www.ama-assn.org/delivering-care/ethics/commercial-use-human-biological-materials (last visited Jan. 3, 2021). [2]Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990) [3]Greenberg v. Miami Children's Hospital Research Institute, 264 F. Suppl. 2d, 1064 (SD Fl. 2003) [4]Washington University v. Catalona, 490 F 3d 667 (8th Cir. 2007) [5]Medical Research Council [MRC], Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines, 2019, https://mrc.ukri.org/publications/browse/human-tissue-and-biological-samples-for-use-in-research/ (last visited Jan. 3, 2021). [6]Wen-Hui Chiu, The legal entitlement of human body, tissue and derivatives in civil law, Angle Publishing, 2016, at 327. [7]id, at 341. [8]Okano, M., Takebayashi, S., Okumura, K., Li, E., Gaudray, P., Carle, G. F., & Bliek, J. UKCCCR guidelines for the use of cell lines in cancer research.Cytogenetic and Genome Research,86(3-4), 1999, https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC2363383&blobtype=pdf (last visited Jan. 3, 2021).
Taiwan Planed Major Promoting Program for Biotechnology and Pharmaceutical IndustryTaiwan Government Lauched the “Biotechnology Action Plan” The Taiwan Government has planned to boost the support and develop local industries across the following six major sectors: biotechnology, tourism, health care, green energy, innovative culture and post-modern agriculture. As the biotechnology industry has reached its maturity by the promulgation of "Biotech and New Pharmaceutical Development Act" in July, 2007, it will be the first to take the lead among the above sectors. Thus, the Executive Yuan has launched the Biotechnology Action Plan as the first project in building the leading industry sectors, to upgrade local industries and stimulate future economic growth. Taiwan Government Planed to Promote the Biotechnology and Other newly Industries by Investing Two Hundred Billion To expand every industrial scale, enhance industrial value, increase the value around the main industrial field, and to encourage the industrial development by government investments for creating the civil working opportunities to reach the goal of continuous economic development, the Executive Yuan Economic Establishment commission has expressed that, the government has selected six newly industrials including "Biotechnology", "Green Energy", "Refined Agriculture", "Tourism", "Medicare", and "Culture Originality" on November 19, 2009 to promote our national economic growth. The government will invest two hundred billion NT dollars to support the industrial development aggressively and to enhance the social investments from year 2009 to 2012. According to a Chung-Hua Institution for Economic Research report, the future growth rate will reach 8.16% after the evaluation, Hence, the future of the industries seems to be quite bright. Currently, the government plans to put money into six newly industries through the existing ways for investment. For instance, firstly, in accordance with the "Act For The Development Of Biotech And New Pharmaceuticals Industry" article 5 provision 1 ",for the purpose of promoting the Biotech and New Pharmaceuticals Industry, a Biotech and New Pharmaceuticals Company may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to thirty-five percent (35%) of the total funds invested in research and development ("R&D") and personnel training each year; provided, however, that if the R&D expenditure of a particular year exceeds the average R&D expenditure of the previous two years or if the personnel training expenditure of a particular year exceeds the average personnel training expenditure of the previous two years, fifty percent (50%) of the amount in excess of the average may be used to credit against the amount of corporate income tax payable. Secondly, according to same act of the article 6 provision 1 ", in order to encourage the establishment or expansion of Bio tech and New Pharmaceuticals Companies, a profit-seeking enterprise that (i) subscribes for the stock issued by a Biotech and New Pharmaceuticals Company at the time of the latter's establishment or subsequent expansion; and (ii) has been a registered shareholder of the Biotech and New Pharmaceuticals Company for a period of three (3) years or more, may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to twenty percent (20%) of the total amount of price paid for the subscription of shares in such Biotech and New Pharmaceuticals Company; provided that such Biotech and New Pharmaceuticals Company has not applied for exemption from corporate income tax or shareholders investment credit based on the subscription price under other applicable laws and regulations. Thirdly, to promote the entire biotechnological industry development, the government has drafted the "Biotechnology Takeoff Package" for subsidizing the startup´s social investment companies which can satisfy the conditions to invest in "Drug discovery", "Medical Device" or other related biotech industries up to 5 billion with the capital invest in domestic industry over 50%, , with operating experience of multinational biotech investment companies with capital over 150 million in related industrial fields, and with the working experiences of doctor accumulated up to 60 years. Additionally, the refined agriculture industry field has not only discovered the gene selected products, but also combined the tourism with farming business for new business model creation. According to the "Guidelines for Preferential Loans for the Upgrading of Tourism Enterprises" point 4 provision 1, the expenditure for spending on machine, instruments, land or repairing can be granted a preferential loan in accordance with the rule of point 6, and government will provide a subsidy of interest for loaning Tourism Enterprises with timely payments. At last, Council for Economic Planning and Development also points out because most of technology industry has been impacted seriously by fluctuation of international prosperity due to conducting the export trade oriented strategy. Furthermore, the aspects of our export trade of technology industry have been impacted by the U.S. financial crisis and the economic decay in EU and US; and the industrial development seems to face the problem caused by over centralization in Taiwan. Hence, the current framework of domestic industry should be rearranged and to make it better by promoting the developmental project of six newly industries. Taiwan Government Had Modifies Rules to Accelerate NDA Process and Facilitate Development of Clinical Studies in Taiwan In July 2007, the "Biotech and New Pharmaceutical Development Act" modified many regulations related to pharmaceutical administration, taxes, and professionals in Taiwan. In addition, in order to facilitate the development of the biotechnology and pharmaceutical industries, the government has attempted to create a friendly environment for research and development by setting up appropriate regulations and application systems. These measures show that the Taiwanese government is keenly aware that these industries have huge potential value. To operate in coordination with the above Act and to better deal with the increasing productivity of pharmaceutical R&D programs in Taiwan, the Executive Yuan simplified the New Drug Application (NDA) process to facilitate the submission that required Certificate of Pharmaceutical Product (CPP) for drugs with new ingredients. The current NDA process requires sponsors to submit documentation as specified by one of the following four options: (1) three CPPs from three of "ten medically-advanced countries," including Germany, the U.S., England, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden; (2) one CPP from the U.S., Japan, Canada, Australia, or England and one CPP from Germany, France, Switzerland, Sweden, or Belgium; (3) a Free Sale Certificate (FSC) from one of ten medically-advanced countries where the pharmaceuticals are originally produced and one CPP from one of the other nine countries; or (4) a CPP from the European Medicines Agency. Thus, the current NDA process requires sponsors to spend inordinate amounts of time and incur significant costs to acquire two or three FSCs or CPPs from ten medically-advanced countries in order to submit an NDA in Taiwan. According to the new rules, sponsors will not have to submit above CPPs if (1) Phase I clinical studies have been conducted in Taiwan, and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country or (2) Phase II and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country. Besides, the required minimum numbers of patients were evaluated during each above phase. Therefore, sponsors who conduct clinical studies in Taiwan and in another country simultaneously could reduce their costs and shorten the NDA process in Taiwan. The new rules aim to encourage international pharmaceutical companies to conduct clinical studies in Taiwan or to conduct such studies cooperatively with Taiwanese pharmaceutical companies. Such interactions will allow Taiwanese pharmaceutical companies to participate in development and implementation of international clinical studies in addition to benefiting from the shortened NDA process. Therefore, the R&D abilities and the internationalization of the Taiwanese pharmaceutical industry will be improved.
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